k.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
adminMTE_04792024-02-26T11:42:11+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) issued on April 20th four technical documents covering cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER). Following, a short overview on the content of the guidelines: [...]
k.janecek2024-02-07T15:52:28+00:00April 24th, 2020|Categories: Covid-19, Europe, MDR, Regulatory|Tags: Europe, European Commission, MDR|
Medical devices can be sold for another year under the current regulatory framework based on the EU Medical Device Directive (93/42/EEC). The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone [...]
adminMTE_04792024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
adminMTE_04792024-02-26T16:52:20+00:00April 17th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance temporarily allowing postponement or remote audits of medical device manufacturers necessary for the re-certification of CE marking and related requirements. Normally, manufacturers must undergo on-site audits by Notified [...]
adminMTE_04792024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
k.janecek2024-02-01T16:43:42+00:00April 15th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory|Tags: Clinical Trial, Columbia, Covid-19, Regulatory|
In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 "By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19" , it [...]
k.janecek2024-02-26T11:12:52+00:00March 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
On March 26, 2020, the BfArM published "Additional recommendations on the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic " for clinical trials with medicinal products. All recommendations are aimed at: continue to ensure [...]
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